White Paper

New Era in Digital Compliance, Quality and Risk Management (CQRM)

The COVID-19 pandemic has expedited the requirement for digital transformation within the Life Sciences Industry, creating a new era in digital quality management. As new quality management processes are brought to life, leading life sciences companies are experiencing how digital transformation is an opportunity to overcome regulatory challenges and modernize their business processes. Life science leaders are leveraging a new generation of CQRM systems to supports the product life cycle from preclinical to launch and beyond.

The new era in quality, compliance, and risk management establishes the need for intelligent digital workplaces as an elaborate, unified ecosystem of product quality excellence. The latest innovative technologies of the digital CQRM system provide 21 CFR part 11 compliance, e-audit, e-inspection, e-Sourcing, and e-reporting unified with the core process of R&D manufacturing, clinical operations, etc. Experts can now leverage the digital CQRM systems holistically and remotely on the cloud.

To be effective in the new era of electronic quality management, all companies need to:

  • Re-imagine all processes for R&D, lab operating systems, and policies to enable continuous data integrity and enable a unified operational ecosystem.
  • Create a new paradigm for the post-COVID-19 world of holistic digital quality management.
  • Always be ready for e-Audit, e-Sourcing, and e-Inspections.
  • Bring innovation to markets at rapid speeds with full regulatory compliance in the digital workplace.

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A cloud based Compliance, Quality & Risk Management platform unified with R&D, Labs, Predictive Risk, Clinical, Manufacturing, and Document Management